Job Description:As the Regulatory Affairs Manager you will represent Regulatory Affairs for pharmaceutical development projects and marketed products as assigned. Working with development teams, identifying and compile required documentation for regulatory submissions. Serve as regulatory subject matter expert to advise technical operations on regulatory best practices for pharmaceutical development and cGMP manufacturing. Actively participate and potentially lead cross functional teams and regulatory projects.
Responsibilities:- Support CMC-themed regulatory interactions (submissions and responses) from regulatory agencies (FDA and global) by providing CMC and regulatory expertise.
- Interface with Roseville CMC teams to better understand process development and status so as to better support regulatory interactions.
- Organize and coordinate SME meetings in preparation for regulatory interactions (preIND, SNSA, ITF...)
- Evaluate microbiome-related change control documents for regulatory impacts or perspectives.
- Interface with global regulatory to align clinical and CMC perspectives.
- Participate in program development team meetings to reach decisions on regulatory submission strategies.
- Author and coordinate authoring of CMC regulatory submission documents.
Requirements:- Required Education/Qualifications: BS degree or equivalent in a scientific field; microbiology, pharmacology specialization a plus. Degree in regulatory affairs or advanced degree is preferred.
- Years of Experience: 3 years of regulatory experience; augmentable with quality or CMC development experience; experience in microbiome therapeutics is highly regarded.
- Subject Matter Expertise: pharmaceutical product development, regulation, quality; medical, regulatory, or other technical writing; expertise in live biotherapeutics a plus; project management expertise a plus
Ferring + you At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry's most impressive people, these are just some of the ways we live our "People First" philosophy.
Our Compensation and Benefits At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $119,575 to $222,067 which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.
Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, sick time of 1 hour per 30 hours worked, vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 15 paid holidays per year. We are proud to offer paid parental leave subject to a minimum period of employment at Ferring.
Location:Roseville, Minnesota
